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临床试验/NCT01588756
NCT01588756已完成1 期

Development of a New Non-radioactive Test for Measuring Glomerular Filtration Rate Using the Tetrapeptide N-acetyl-Ser-Asp-Lys-Pro-amide (AcSDKP-NH2)

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
100
试验地点
1
主要终点
glomerular filtration rate

研究概览

简要总结

The purpose of the study is to validate a new reference marker for evaluation of renal function (glomerular filtration rate).

详细描述

Chronic kidney disease (CKD) is a worldwide public health problem with an increasing incidence and prevalence, poor outcomes (kidney failure, complications of decreased kidney function and cardiovascular disease), and high cost. Some of the adverse outcomes can be prevented or delayed by early detection and treatment. However, CKD is frequently underdiagnosed and undertreated. The glomerular filtration rate (GFR) is considered as the best index of renal function. The clinical action plan promoted by International Guidelines groups refers to GFR values. Despite recent improvements, prediction equations developed in order to estimate GFR elicit a huge lack of accuracy when considering the individual patient, especially in case of early CKD. Rigorous assessment of GFR requires the measurement of urinary or plasma clearance of an ideal exogenous filtration marker which is either non-radioactive (inulin, iothalamate, or iohexol) or radioactive ( 51Cr-EDTA or 99mTc DTPA. Measuring clearance with the use of exogenous markers is difficult to perform in clinical practice because it is expensive and cumbersome and needs specialised laboratories and thus, is underused. There is an unmet need for the development of a new non-radioactive GFR tracer that could combine both the analytical accuracy of radioactive tracers and the simplicity of its measurement. Such a tracer should improve clinical care and follow-up of patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Phase I: 18-35 years male
  • Phase I: healthy volunteers
  • Phase II: 18-80 years patients (both sex)
  • Phase II: with Chronic Kidney Disease

排除标准

  • Phase I: Smokers
  • Phase I: Allergic

研究组 & 干预措施

AcSDKP-NH2 inuline

Experimental

AcSDKP-NH2 inuline, Once intravenous administration of 100 µg or less

干预措施: AcSDKP-NH2 inuline (Drug)

AcSDKP-NH2 Cr-EDTA

Experimental

AcSDKP-NH2 Cr-EDTA, Once intravenous administration of 100 µg or less

干预措施: AcSDKP-NH2 Cr-EDTA (Drug)

结局指标

主要结局

glomerular filtration rate

时间窗: between day 7 and day 21

NAcSDKP clearance for GFR measurement is compared to inuline and 51Cr-EDTA clearance in two phase I studies in 50 healthy subjects. GFR is first assessed at equilibrium by measuring urinary clearances of inuline and NAcSDKP continuously co-infused after a loading dose; and second by plasma clearances of 51Cr-EDTA and NAcSDKP after a single IV bolus. Optimal conditions for using NAcSDKP as a marker for GFR and the tolerability of the peptide are assessed during these studies. Then, a phase IIa study will be performed to compare the 2 methods in 45 patients with various degrees of renal failure.

次要结局

  • safety(One month extended to 3 months safety follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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